BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON

    MDR report key: 19735600 · Received July 12, 2024

    Report

    Report Number
    2028807-2024-00016
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    May 17, 2024
    Report Date
    July 12, 2024
    Manufacturer
    WESTMED LLC
    Product Code
    CAF
    UDI-DI
    20612479203376
    PMA / PMN Number
    K926055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 12 JUL 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED, DURING PATIENT USE, THE MEDICINE BUBBLED INSIDE THE CUP BUT DID NOT MIST OUT OF THE CUP. IT WAS ADDITIONALLY REPORTED, IT APPEARED TO NOT TO BE SITTING PROPERLY. THE EVENT OCCURRED DURING HOME USE; THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903304 MCKESSON NEBULIZER KIT, T PIECE, MOUTHPIECE 6 CAF WESTMED LLC 32642 UNKNOWN 20612479203376

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown